Nicotine Recall: Aveva Patch 14 mg
FDA recall for Aveva Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Lot 56841, expiration 03/2028, distributed nationwide in the U.S. The recall is due to elevated levels of oxidative-related impurities exceeding shelf-life specifications during stability testing of individual units. A total of 59,808 pouches (4,272 IFC) are affected.
| Brand | AVEVA Drug Delivery Systems, Inc. |
|---|---|
| Product | Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88. |
| Reason | Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. |
| Severity | low |
| Units affected | 59808 |
| Distribution | Nationwide within the U.S |
| Agency | FDA |
WHAT YOU SHOULD DO
- If you have patches from Lot 56841, stop using them immediately.
- Contact Rugby Laboratories for return/disposal instructions and follow FDA recall updates.
- Keep the packaging and product information for reference until the recall is resolved.
How to identify the recalled item
| Lot / date codes | Lot #: 56841, Expires: 03/2028 |
|---|---|
| Lot / date codes | Lot #: 56841, Expires: 03/2028 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.